Enhancing CLIA Act of 2026

(a) Effective date. Except as otherwise provided in this section, the amendments made by this Act shall take effect immediately upon enactment.

(b) Transition and regulations

(1) The Secretary of Health and Human Services (in this subsection referred to as the Secretary) shall take the following actions, and may expend such funds as the Secretary determines necessary to ensure an orderly transition—

(A) within 180 days of enactment, promulgate proposed regulations required under the amendments made by this Act;

(B) within 2 years of enactment, establish the centralized database for laboratory developed tests under section 353(r)(2) of the Public Health Service Act, as added by section 2(a) of this Act;

(C) within 2 years of enactment, promulgate final regulations to mitigate potential conflict of interest by organizations that provide multiple oversight services under section 353 of the Public Health Services Act (42 U.S.C. 263a), including accreditation of laboratories, proficiency testing, and supplemental affirmation for laboratory developed tests; and

(D) within 30 days of enactment, revise the definition of in vitro diagnostic products at section 809.3 of Title 21 of the Code of Federal Regulations, effective immediately, to clarify that such term—

(i) does not include laboratory developed tests as defined in subsection (a) of section 2 of this Act; and

(ii) includes protocols for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae when such protocols are— except that such protocols are not commercially distributed solely because they are published, including in public or scientific presentations, or patented.

(I) commercially distributed for performance in laboratories not under common ownership by the same parent corporation as the laboratory that developed the protocol; or

(II) commercially distributed by an entity or individual that is not a laboratory;

(2) Applicability of regulations. Notwithstanding the date on which regulations are issued under paragraph (1), no regulations issued pursuant to the amendments made by this Act shall be implemented or take effect until 2 years after enactment, except as otherwise specified in this section.

(c) Conversion

(1) This subsection applies to a laboratory developed test as defined in subsection (a) of section 2 of this Act that has—

(A) a premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e), an approved humanitarian device exemption under section 520(m) of such Act (21 U.S.C. 360j(m)), a clearance under section 510(k) of such Act (21 U.S.C. 360(k)), an authorization under section 513(f)(2) of such Act (21 U.S.C. 370c(f)(2)), an investigational device exemption under section 520(g) of such Act (21 U.S.C. 360j(g)), or a licensure under section 351 of the Public Health Service Act (42 U.S.C. 262); or

(B) a premarket approval application under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e), an application for humanitarian device exemption under section 520(m) of such Act (21 U.S.C. 360j(m)), a premarket notification under section 510(k) of such Act (21 U.S.C. 360(k)), a de novo classification request under section 513(f)(2) of such Act (21 U.S.C. 370c(f)(2)), an investigational device exemption under section 520(g) of such Act (21 U.S.C. 360j(g)), or an application for licensure under section 351 of the Public Health Service Act (42 U.S.C. 262) pending on the date of enactment.

(2) Notwithstanding any other provision of this Act, a laboratory developed test under paragraph (1) shall be a device under section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)(1)) until—

(A) if a notification is submitted under paragraph (3)(A), the date of such notification; or

(B) if a notification is submitted under paragraph (3)(B), the earlier of—

(i) approval, clearance, authorization, exemption, or licensure of a modification to such test such that it meets the definition of device under section 201(h)(1) of such Act (21 U.S.C. 321(h)(1));

(ii) 2 years after enactment;

(iii) the date a subsequent notification is submitted under paragraph (3)(A); or

(iv) 60 days after enactment if no notification is submitted under paragraph (3).

(3) For a laboratory developed test under paragraph (1), within 60 days of enactment, a laboratory may submit to the Food and Drug Administration a notification that the laboratory—

(A) does not intend to modify the test to meet the definition of a device under section 201(h)(1) of the Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)(1)); or

(B) intends to modify the test to meet the definition of a device under section 201(h)(1) of the Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)(1)).

(4) For a laboratory developed test under paragraph (1)(A), upon the applicable date in paragraph (2) that such test is no longer a device, such test is deemed to have a supplemental affirmation from the Food and Drug Administration under section 353(r)(1)(D) of the Public Health Service Act (42 U.S.C. 263a(r)(1)(D)), as added by section 2(a) of this Act, that the laboratory developed test meets the applicable standard.